Regulatory Account Manager
Join Accenture and help transform leading organizations and communities around the world. The sheer scale of our capabilities and client engagements and the way we collaborate, operate and deliver value provides an unparalleled opportunity to grow and advance. Choose Accenture, and make delivering innovative work part of your extraordinary career.
The Regulatory Account Manager will be accountable for delivery of contracted commitments within budget and accuracy of all project information including, forecasts, costing and timelines for projects.
- Develop regulatory solutions, risk assessment and management, implementation, execution and continuous improvement
- Responsible for development of new initiatives, performance of Accenture Regulatory Operations staff and ensuring the success of the Accenture Accelerated Research and Development business goals
- Provide project leadership and management expertise to deliver client regulatory projects
- Act as the primary point of contact for project execution, coordinating internal efforts to meet expected timelines, quality, and budget, and aligning expectations with clients for contracted deliverables
- Coordinate and prioritization of global operational resources responsible for the publishing of all types of global submission filings in multiple submission formats
- Drive improved capacity management of global operational resources
- Create and maintain all strategic partnerships (internal and external) through consistent communication and clear direction
- Adhere to sound account management principles, account for delivery of contracted commitments within budget and accuracy of all project information including, forecasts, costing and timelines for projects associated with the assigned portfolio of projects; and minimizing EACs
- Support client relationship development, account planning and growth, including identification of new opportunities, tailoring business development activities to the specific client environment, and achieving targeted revenue and CCI for their portfolios, including implementing recovery plans
- Client relationship management, building relationships with clients and potential clients, leading to growth of assigned accounts
- Foster seamless interaction between Accenture's and client's product teams and regulatory affiliates
- Ensure training and SOP Compliance; maintaining a strong working knowledge of standard operating procedures and regulatory guidance applicable to project scope (including corrective action plans and identifying trends)
- Account for project performance (service level agreements and key performance indicators), quality management
- Provide regulatory domain support for business development, including providing and developing innovative delivery solutions, creating materials for and participation in sales pursuits, key client meetings, bid defenses for RFI's and RFP's
- Responsible for review and approval of contract language, as related to regulatory services
- Create and deliver presentations, internally and externally (to clients/industry)
- Assist leadership in the definition and achievement of departmental goals
- Build on established regulatory reputation through work with clients, health authorities and trade associations and through developing specialized areas of expertise
- Support other capability building activities, as needed, including design of new templates, documentation of best practices, conduct of lessons learned meetings, and other sanctioned activities to improve operational excellence
+ Basic qualifications
- Bachelor's degree
- Minimum of 7 years' experience with managing clients
- Knowledge of pharmaceutical regulatory submission requirement
- Ability to travel
- Excellent organizational, multi-tasking, time-management skills; and effective at managing many competing projects
- Proven abilities to lead and/or work with multidisciplinary project teams across multiple geographic locations to build collaborative relationships
- Proven abilities to establish excellent working relationships with clients, peers and team members through integrity, credibility, reliability and trust
- Proven abilities to manage and transform complex regulatory projects
- Proven abilities to anticipate and address stakeholder needs in problem solving and risk mitigation
- Self-directed, self-motivated individual with initiative and an ability to work in a fast paced, high volume environment
- Ability to promote the professional growth of self and others to achieve individual and organizational goals
- People oriented with a mindset for customer service
- Experience in, and understanding of the CRO environment are required
- Thorough knowledge of medical terminology
- Knowledge of good clinical practices and other applicable regulations
- Knowledge of quality assurance processes in a FDA regulated software development environment
Applicants for employment in the US must have work authorization that does not now or in the future require sponsorship of a visa for employment authorization in the United States and with Accenture (i.e., H1-B visa, F-1 visa (OPT), TN visa or any other non-immigrant status).
Candidates who are currently employed by a client of Accenture or an affiliated Accenture business may not be eligible for consideration.
Accenture is a Federal Contractor and an EEO and Affirmative Action Employer of Females/Minorities/Veterans/Individuals with Disabilities.
Equal Employment Opportunity
All employment decisions shall be made without regard to age, race, creed, color, religion, sex, national origin, ancestry, disability status, veteran status, sexual orientation, gender identity or expression, genetic information, marital status, citizenship status or any other basis as protected by federal, state, or local law.
Job candidates will not be obligated to disclose sealed or expunged records of conviction or arrest as part of the hiring process.
Accenture is committed to providing veteran employment opportunities to our service men and women.
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